Name/Company | Approval Dates and Comments |
Ceftobiprole Zeftera® Johnson & Johnson/ Basilea Pharmaceuticals | The US FDA rejected the New Drug Application for this antibiotic |
IV Iclaprim Arpida Ltd. | The Therapeutic Products Directorate of Health Canada received, in September |
HPV Vaccine Gardasil® Merck & Co. | The US FDA approved additional indications for this HPV vaccine in September |
Alitretinoin Toctino® Basilea Pharmaceuticals | The Danish Medicines Agency (DKMA) approved this once-daily oral treatment in September 2008 for the treatment of adults with severe chronic hand eczema that is unresponsive to potent topical corticosteroids. Marketing applications for this product are also under review in Canada and Switzerland. |
Atazanavir sulfate REYATAZ® Bristol-Myers Squibb | The US FDA approved the use of this 300mg once daily product in October 2008 to be boosted with ritonavir 100mg once daily as part of a combination therapy in treatment naïve HIV-1 infected adult patients. |
Drug News |
In October 2008, Genentech issued a Dear Healthcare Provider letter to inform |
The US FDA notified healthcare professionals in November 2008 that it is investigating |